BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CB-X II DUAL-ENDED CLEANING BRUSH

    MDR report key: 1190691 · Received October 3, 2008

    Report

    Report Number
    8030647-2008-00016
    Event Type
    Malfunction
    Date Received
    October 3, 2008
    Date of Event
    September 3, 2008
    Report Date
    September 30, 2008
    Manufacturer
    AVENT S. DE R.L. DE C.V.
    Product Code
    FEB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INCIDENT SAMPLE HAS NOT YET BEEN RECEIVED. INVESTIGATION IS IN-PROCESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL RELEVANT INFORMATION. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT & MDR TREND REPORTING SYSTEMS. ONGOING ANALYSIS OF TREND INFORMATION IS USED TO IDENTIFY THE NEED FOR ADDITIONAL INVESTIGATIONS.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED BY KIMBERLY CLARK SALES REPRESENTATIVE THAT THE BRUSH PORTION ALLEGEDLY SEPARATED FROM THE CATHETER AND WAS LEFT BEHIND IN THE FLEXIBLE ENDOSCOPE. DURING A PATIENT PROCEDURE AS THE BIOPSY FORCEP WAS PUSHED THROUGH THE BIOPSY PORT/LUMEN, AND BRUSH TIP WAS FORCED OUT OF THE ENDOSCOPE INTO THE PATIENT. NO PATIENT HARM OCCURRED AND THE TIP WAS RETRIEVED. KIMBERLY-CLARK HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. (B) (4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CB-X II DUAL-ENDED CLEANING BRUSH DISPOSABLE CLEANING BRUSH FEB AVENT S. DE R.L. DE C.V. M 154E301

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention